Download - Quality Management - Why Should I Care?
Choices
! Systems:
! ISO 9000 series
! AS9100
! TS 16949
! ISO 13485
! Registrar (Certification Body)
What problem is being solved?
! Customer Satisfaction
! Meet or exceed customer and regulatory requirements
! Continual Improvement
What is the solution?
! Customized by each organization for its size, needs, objectives, products, etc.
! Process Approach – a managed set of activities using resources to transform inputs into outputs
! Meeting requirements
! Added value
! Performance/Effectiveness using objective measurements
! Accountability and trust through registration (certification)
Requirements of AS9100 (ISO9001)
! Quality Manual with documented procedures
! Documents/Records as necessary for effective planning and control of processes
! Records provide evidence of QMS effectiveness and conformity to requirements
4.2.3 Control of Documents “A documented procedure shall be established to define the controls needed”
Control of Documents
! Approve for adequacy prior to issue
! Review & Update as needed (re-approve)
! Changes and current revision identified
! Relevant versions available at point of use
! Documents remain legible and identifiable
! Control distribution of external origin documents
! Prevent unintended use of obsolete documents
Planning
! Key aspects of the product (requirements, objectives)
! Project Management
! Risk Management
! Configuration Management
! Control of work transfers
Configuration Management
! Apply technical and administrative direction over the life cycle of a product
! Configuration Items
! Product Configuration Information
! Documents a product’s configuration
! Identification
! Traceability
! Status in meeting requirements
! Accurate information
! Assign Responsibilities
Configuration Management Benefits
! Product attributes are defined – measurable performance parameters provide common basis for buyer and seller
! Know basis for making changes – decisions are based on correct, current information
! Product repeatability is enhanced
! Products are labeled and correlated with associated documentation – data is available to avoid guesswork
! Proposed changes are identified and evaluated for impact prior to making change decisions – downstream surprises are minimized
Potential Problems without CM
! Equipment failure due to incorrect part replacement
! Schedule delays & increased cost due to unanticipated changes
! Operation delays due to mismatches with support equipment
! Maintenance down-time and cost increase due to inconsistencies between equipment and instructions
Customer-related processes
! Determination of requirements
! Requirements review
! Customer communication
Design and Development
! Planning
! Inputs
! Outputs
! Review
! Verification
! Validation
! Control of Changes
Product processes
! Purchasing
! Production and Service Provision
! Drawings, Parts Lists, Work Instructions, Tooling, Test Equipment
! Process Verification (FAI)
! Control of Measuring and Monitoring Equipment
Why care about QMS?
Eventually it is about pleasing the customer, which results in benefit for everyone in the company.